Bridging study? [Design Issues]

posted by d_labes  – Berlin, Germany, 2020-06-11 18:27 (108 d 03:17 ago) – Posting: # 21528
Views: 473

Dear Libaiyi,

» Now I met a study design and analysis method problem. I had PK data from US. And now this drug needs to be put into other regions such as Asia. So we setup a new study, it is a single arm trial. How can I compare the PK data from the new trial to historical US PK data?

Like Helmut I also never came across such a design during my active working period.

But eventually your problem is something like "Bridging study".
Have a look into the paper
Jen-pei Liu
'Bridging Bioequivalence Studies'
J Biopharm Stat. 2004 Nov;14(4):857-67.
doi: 10.1081/BIP-200035418

This paper is also handled in
Shein-Chung Chow, Jen-pei Liu
Design and Analysis of Bioavailability and Bioequivalence Studies
Third Edition, Chapter 20.3
Chapman & Hall/CRC
Boca Raton 2009

Regards,

Detlew

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